Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00468715
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2007-05-02
Brief Title:
Bicalutamide in Treating Patients With Metastatic Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Bicalutamide for the Treatment of Androgen Receptor Positive AR Estrogen Receptor Negative Progesterone Receptor Negative ER-PR- Metastatic Breast Cancer Patients A Phase II Feasibility Study
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Androgens can cause the growth of breast cancer cells Antihormone therapy such as bicalutamide may stop the adrenal glands from making androgens
PURPOSE This phase II trial is studying how well bicalutamide works in treating patients with metastatic breast cancer
PURPOSE This phase II trial is studying how well bicalutamide works in treating patients with metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the 6-month efficacy rate of bicalutamide as first- second- or third-line therapy in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer
Secondary
Determine the 6-month progression-free survival of patients treated with this drug
Evaluate the safety of this drug in these patients
Evaluate changes in estradiol total and free testosterone and sex-hormone binding globulin in response to androgen blockade in patients treated with this drug
Evaluate tissue including cytokeratins 56 and 17 SPDEF ALCAM ERBB2 FGFR4 and prostate-specific antigen PSA using immunohistochemical analysis in patients treated with this drug
OUTLINE This is a open-label study
Patients receive oral bicalutamide once daily for 4 weeks Treatment repeats every 4 weeks for 6 months in the absence of disease progression or unacceptable toxicity Patients achieving complete response partial response or stable disease may continue to receive bicalutamide as above at the discretion of the investigator
Patients undergo blood and tissue sample collection for correlative studies Samples are analyzed for hormonal levels including estradiol total testosterone free testosterone and sex-hormone binding globulin and proteins including ALCAM SPEDF and CK 56 by immunohistochemical analysis at baseline after course 1 and at the end of the study
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study
Primary
Determine the 6-month efficacy rate of bicalutamide as first- second- or third-line therapy in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer
Secondary
Determine the 6-month progression-free survival of patients treated with this drug
Evaluate the safety of this drug in these patients
Evaluate changes in estradiol total and free testosterone and sex-hormone binding globulin in response to androgen blockade in patients treated with this drug
Evaluate tissue including cytokeratins 56 and 17 SPDEF ALCAM ERBB2 FGFR4 and prostate-specific antigen PSA using immunohistochemical analysis in patients treated with this drug
OUTLINE This is a open-label study
Patients receive oral bicalutamide once daily for 4 weeks Treatment repeats every 4 weeks for 6 months in the absence of disease progression or unacceptable toxicity Patients achieving complete response partial response or stable disease may continue to receive bicalutamide as above at the discretion of the investigator
Patients undergo blood and tissue sample collection for correlative studies Samples are analyzed for hormonal levels including estradiol total testosterone free testosterone and sex-hormone binding globulin and proteins including ALCAM SPEDF and CK 56 by immunohistochemical analysis at baseline after course 1 and at the end of the study
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-07022 | None | None | None |